QA Computer Systems Validation Engineer I

Employer
Bachem
Location
92081, Vista
Posted
Apr 08, 2019
Required Education
Bachelors Degree
Position Type
Full time

Your Tasks

  • Ensure compliance of relevant computer systems and applications with regulatory requirements and controls associated with CFR 21 Part 11 and EU GMP Annex 11
  • Development and maintenance of life cycle documents necessary to address the validation lifecycle (Risk assessments, validation plan, SOP, etc.)
  • Work directly with local and Central QA departments
  • Participate in  site Projects and manage all activities in regards to validation and qualification of computer systems and applications
  • Represent CSV implementation during regulatory inspections and partner audits and provide CSV related responses to inspectors/auditors

Your Profile

  • Bachelor’s Degree in Computer Science or Science with 5 years’ experience
  • Proven track record in validation and qualification of complex computer systems
  • Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, GAMP, and data integrity standards
  • Experience with writing, reviewing and executing computer validation documentation (Validation plan, IQ, OQ, DQ, SOP, Specifications, Risk assessments)
  • Excellent written and oral communication skills
  • Excellent computer knowledge, including Microsoft Word, Excel and PowerPoint
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one’s time
  • Communicate effectively and ability to function well in a team environment

Preferred:

  • Experience with CSV in regards to new technologies (e.g. virtualization and cloud (SaaS)

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.